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US FDA, Div Pharmacovigilance, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Room 3443,Bldg 22,10903 New Hampshire Ave, Silver Spring, MD 20993 USA US FDA, Div Pharmacovigilance, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Room 3443,Bldg 22,10903 New Hampshire Ave, Silver Spring, MD 20993 USA